baclofen

Generic: baclofen

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name baclofen
Generic Name baclofen
Labeler pd-rx pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

baclofen 10 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 43063-864
Product ID 43063-864_415c3642-f324-746e-e063-6294a90a7ae0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078220
Listing Expiration 2026-12-31
Marketing Start 2007-07-01

Pharmacologic Class

Established (EPC)
gamma-aminobutyric acid-ergic agonist [epc]
Mechanism of Action
gaba a agonists [moa] gaba b agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43063864
Hyphenated Format 43063-864

Supplemental Identifiers

RxCUI
197391 197392
UPC
0343063865309 0343063864906
UNII
H789N3FKE8
NUI
N0000000196 N0000000116 N0000175759

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name baclofen (source: ndc)
Generic Name baclofen (source: ndc)
Application Number ANDA078220 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE, PLASTIC (43063-864-30)
  • 60 TABLET in 1 BOTTLE, PLASTIC (43063-864-60)
  • 90 TABLET in 1 BOTTLE, PLASTIC (43063-864-90)
source: ndc

Packages (3)

43063-864-30 30 TABLET in 1 BOTTLE, PLASTIC (43063-864-30) 43063-864-60 60 TABLET in 1 BOTTLE, PLASTIC (43063-864-60) 43063-864-90 90 TABLET in 1 BOTTLE, PLASTIC (43063-864-90)

Ingredients (1)

baclofen (10 mg/1)

Linked Drug Pages (1)

Baclofen ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "415c3642-f324-746e-e063-6294a90a7ae0", "openfda": {"nui": ["N0000000196", "N0000000116", "N0000175759"], "upc": ["0343063865309", "0343063864906"], "unii": ["H789N3FKE8"], "rxcui": ["197391", "197392"], "spl_set_id": ["cfcf519f-5d15-431d-89c8-961a0c38ba60"], "pharm_class_epc": ["gamma-Aminobutyric Acid-ergic Agonist [EPC]"], "pharm_class_moa": ["GABA A Agonists [MoA]", "GABA B Agonists [MoA]"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (43063-864-30)", "package_ndc": "43063-864-30", "marketing_start_date": "20180626"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE, PLASTIC (43063-864-60)", "package_ndc": "43063-864-60", "marketing_start_date": "20180626"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE, PLASTIC (43063-864-90)", "package_ndc": "43063-864-90", "marketing_start_date": "20180626"}], "brand_name": "Baclofen", "product_id": "43063-864_415c3642-f324-746e-e063-6294a90a7ae0", "dosage_form": "TABLET", "pharm_class": ["GABA A Agonists [MoA]", "GABA B Agonists [MoA]", "gamma-Aminobutyric Acid-ergic Agonist [EPC]"], "product_ndc": "43063-864", "generic_name": "baclofen", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Baclofen", "active_ingredients": [{"name": "BACLOFEN", "strength": "10 mg/1"}], "application_number": "ANDA078220", "marketing_category": "ANDA", "marketing_start_date": "20070701", "listing_expiration_date": "20261231"}